Genetic Test Stewardship:  Perspective on Evidence, Coding and Quality

Genetic Test Stewardship: Perspective on Evidence, Coding and Quality

you very much, Mike. I’m going to bottle that up
and save if for the hard days because that was really a
lovely reflection on my career. So I also want to just
thank [? Rona ?] [? Jack ?] for suggesting this topic
and me as a speaker. I’m really excited to get
to talk with you all today. And it’s always fun
to get an opportunity to put together a
new talk and maybe have some new nuggets for people
I get to work with everyday so they won’t get bored. So I don’t have any
financial disclosures. I am supported by work through
EviCore and other things. But all of that is separate from
my work at Seattle Children’s. So today through the
talk, we’re going to talk about the role
of genetic counselors in laboratory
tests stewardships, specifically in genetic
test stewardship. We will go into some detail
about coding and reimbursement for genetic tests as well as
the insurance authorization process. I’ll try and keep it engaging. It is work that I
find very interesting, but I recognize that not
everyone feels the same way. So let’s get started. What is laboratory
stewardship, and why should we care about it? So definitions are important. Many of you may be familiar
with previous terminology, utilization management. And we’ve shifted to
this new term which has a more positive
sort of spin to it and is really referring
to responsible use of limited health care dollars,
ensuring that we’re only doing testing that is really
appropriate for patients. And put simply, it’s
this value equation. So we can increase
the value of testing if we’re having a careful
consideration of the quality of the test divided by cost. And so it aligns with
antimicrobial stewardship, and we’re in good
company with them. And the philosophy
is really the same. And I think by
piggybacking on that, we can turn utilization management
into a more positive view and get people on board
with this movement. So stewardship involves
improving these, the following four areas– so misordering tests,
misinterpreting test results, failure to retrieve and
act on test results, and these top three are
the top three reasons for lab-related
litigation in the US, so it’s pretty
important to all of us. And then, ultimately,
all of these can have an important
impact on cost to both patients,
us as patients, and to the health care
system as a whole. So it’s important for us
to focus on improving them. In the space of genetic testing,
which is growing exponentially, stewardship is even
more important. So people always talk about
the explosion of genetic tests, but they really are
growing at a rapid rate. And so this is information
from Concert Genetics, who is a provider of– it’s a tool where
you can catalog different genetic
testing options. And their data shows
that 14 new genetic tests enter the market every day. These aren’t novel, new
tests but a variation on a test that was
already in the market but basically adds to the
complexity of the work that genetic counselors
in our role have to do or providers trying
to select tests. And you can see the graph here
on the right-hand side shows the distribution of tests. And so there’s
been a good amount of work in pediatric
and rare disease but also distribution across
other testing domains. So in addition to the increasing
availability of genetic tests, it’s pretty exciting in
terms of the accessibility of genetic tests. I’m sure that all of
you get notifications– or maybe it’s just my phone
because it listens to me all the time– but about 23andMe. Thanksgiving is a great time to
have all your genetic testing performed. It’s easy to do. You just spit in this cup. Or even now, you
just swab your cheek, and you can do your dog,
your child, whomever. So that’s all very
exciting but, again, sort of muddies the water
between what is really clinically useful testing. There’s been an increase
in the complexity of testing costs and coding. And people would
argue with me on costs potentially because
the cost of sequencing has actually really
gone down dramatically over the past several years. But due to coding
challenges and lack of clarity about
how to use codes, the cost to the
insurance payer and then ultimately tests as patients
has gone through the roof, so really an opportunity for us
to consider that and consider interventions to improve it. We see an increase
in orders, especially from nongenetics experts. And I believe– I really feel
the technology is significantly outpacing our practical
understanding of what we actually do with the results. So it’s interesting I found
a variant in that gene that fits the phenotype
for my patient. But what does it actually
mean for them long term? And I think we’re
doing kind of catch-up to really find those answers. And then the definition of
test quality really does vary depending on who
you’re talking to and is an important
consideration in our work doing test stewardship. What is the provider’s
perspective, the patient, the payer,
and us as the laboratory? So that’s the backdrop
for talking about, who are genetic counselors? And why do we have
an important role to play in laboratory
test stewardship? And so many of you may be
familiar with this article published by Chris Miller
and her colleagues. She’s a genetic counselor
at ARUP Laboratories. And this was really
the first paper that clearly documented the
impact genetic counselors can have on identifying order
errors, and improving them, and then the associated
cost savings that can be realized when genetic
counselors are involved. And really, genetic
counselors have been doing this a long time,
but I’m grateful for them for publishing this paper. And really the timing of it
resulted in a nice combination of an opportunity for me to join
the lab at Seattle Children’s and start the
stewardship program. So who are genetic counselors? We have our own Genetic
Counseling Awareness Day, so that’s really exciting. And it’s coming
up on November 4, so give a high-five to your
genetic counselor colleagues. But it’s a master’s level
training program focused on both medical genetics as well
as genetic counseling training. The term actually
was first coined in 1940, which I didn’t know. And the first graduating
class of genetic counselors was out of Sarah
Lawrence College in 1971. And now there’s over
5,000 genetic counselors in the United States
and 7,000 globally. But even with that many,
there is a workforce shortage relative to the amount of
genetic testing and counseling needs, and we’re not
expected to reach an equilibrium for some time. So based on the core skills
of genetic counselors, I would argue that we’re a
pretty good fit for laboratory stewardship, even a great fit. Our skills include being
well-versed in clinical phenotypes and available
testing options– tend to be information
seekers and really wanting to understand what’s
going on with the family and consider the family broadly
in terms of a diagnostic workup and testing algorithms. Our training makes us
knowledgeable about nuances between testing methods and
understanding the broader health care system so
that we can navigate that appropriately. We tend to be pretty
good team players, then problem-solving, very
Type A, and then, lastly, skilled in communication,
which I think is pretty important
for this work. My mom often says, you’re doing
that counseling thing to me again. Aren’t you? But in this work, I think it
is important to figure out how we present
information so that we’re respectful of the orders that
are coming in in the situation so that we can achieve the
best outcome for patients. So ultimately, what
we’re trying to do, the goals of genetic
test stewardship are many, which
is to stop errors, to avoid duplicate testing,
to ensure that we’re being– ordering high-quality tests and
are being fiscally responsible. Ideally, we’re able to implement
best-practice algorithms, and then that translates
to standard care models across an institution. We– our core skills
really are in education, so we’re motivated to make
sure providers understand the “why” of why
we’re doing this and be engaged in that process
so that they too can spread the message of stewardship. And then, ultimately,
that should help us align with payers. And really the
focus should all be around the patient and
patient-centered care. OK, so how do we
actually do the work? So I’m going to go through
a little bit of background about tools for
laboratory stewardship and then some examples from
our experience at Seattle Children’s and a couple
of other institutions. So I’m sure you’re familiar
with, or many of you are familiar with, this paper
by Dr. Baird that outlines different stewardship
interventions and their relative
strength at actually having an impact on test orders. So an example of a
gentle intervention, which is usually pretty
easy to implement, would be a flyer,
an educational flyer that tells you the differences
between different tests and why you might select
one test over another. And my colleagues in the
audience can attest to the fact that those are great to provide,
but people can’t find them when they need them,
and they don’t always have the impact that we intend. And then there’s a number of
different interventions here, but some stronger ones would
be privileging, so ensuring that only expert providers
in a specific area really are allowed
to order tests, and they’re hidden
for other providers or requiring high-level
review of orders by an expert, like a genetic counselor
or a pathologist. And so this case
example highlights how that case review
by a genetic counselor can be impactful. And so I– hopefully,
it will give you a feel for what the work
is that we do day to day. So in this case, it’s
a five-year-old female with lower extremity
arthrogryposis, probably a lower motor neuron etiology. And the neurologist involved
requested preauthorization for TRPV4
deletion/duplication analysis. And as part of
our process, we’re involved in review at preauth. And when we reviewed it, it
seemed a little bit unusual. And the assessment was that
the majority of variance are actually sequence variance. And so the appropriate
testing strategy would be starting with
sequencing of that gene, and then we can always reflex
to deletion/duplication later. So that’s what we
got preauth for. That’s what was ordered. The results identified a
pathogenic variant in this gene by sequencing,
confirming the diagnosis of Charcot-Marie-Tooth disease. And fortunately, we
obtained the diagnosis. If it had gone on the
path it was going, we would have potentially
missed that diagnosis. And then the nice
one is that we were able to have cost savings
by doing the testing in a reflexive manner. So inspired by Chris
Miller and wanting to address patient complaints
related to bills received that were a surprise for
genetic tests they didn’t know had been ordered, we implemented
our stewardship program. It’s gone through many
evolutions over time. But currently, we follow this
two-phase review process, and so all genetic
tests were reviewed at the time of preauthorization. So and I’ll walk you
through the details of what that looks like. But essentially, we’re
assessing requests to make sure that
they are appropriate, that it is actually the correct
test and then, once we’ve established that, really
trying to optimize the test. Have we found the best
platform to answer the question that you’re trying to address? Have we done it in a
cost-effective way? And how can we really
find that best option? And we’re doing all that before
insurance authorization is even obtained. And then we do look again
once the test is actually ordered to make sure
that all of the details are correct, that the
authorization hasn’t expired, that we’ve got all of
the details in place to make sure that we’re
ensuring high-quality test when it’s ordered. And all that
information is captured in a database that allows us to
track orders, have consistency across our teammates,
and then capture metrics and give you the
information that I’m going to show you next. So at the time of preauth,
the majority of requests are approved without
any modification. But a percentage
are canceled with– after conversation with
the ordering provider. And then about 20% are modified. And the reasons for
cancellation I think are important to point out. So if we catch duplicate orders,
new information may come along. They submit a preauth
request, and they’re also doing biochemical screening, and
that information may lead them in a different direction. And we’re able to prevent
additional work downstream by stopping the request
at the preauth phase. And then the
modifications are largely related to improving the
documentation or the test rationale so that it’s
clear, and the provider’s know when it goes to
the insurance plan, why do you want this test? How is it going to impact
management– and really kind of ticking the bullets from
the payer’s perspective of how we can get that test authorized. So our goal is really to
ensure that’s a smooth process. And by having these
conversations upfront, we can prevent medical
necessity letters needed later, that sort of thing. And all of this is associated
with pretty significant cost avoidance. And it’s– we continue to
see impact even at the time of order. So you would think, well,
if we did it at preauth, why are we looking again? But we had similar
modification rates. But at the time of
order, we’re catching when insurance authorization
hasn’t been obtained. I also want to
point out there are times when the wrong test was
ordered, and it’s either we either choose to cancel that or
modify it to the correct test. So that intervention
again is helping with improving
the patient safety in the diagnostic testing
process for that patient– and again, associated with
significant cost avoidance, which, at our institution,
about half of our patients are covered by Medicaid. So, much of that money would
go back to the laboratory and support the ongoing
care for our patients. But the other half are
really back to patients, so ensuring that
copays, and deductibles, and things aren’t being paid for
things that aren’t appropriate. So the other
information that I think is important related
to patient safety is capturing information
around diagnostic errors. So this was a publication
that we’ve put together. Actually, Dr. Mathias
did a lot of this work– and Dr. Konnick, who
is in the room as well. We did a bunch of case
review to try and identify by specialty and by setting
what types of orders we would identi– we could see. And the highest
order error rate is from genetics in the
inpatient setting, which might seem like a surprise
to those in the audience, but it’s because the
genetics providers don’t put in their own order. So this is residents who are
translating complex information from an expert and trying to
get the order in correctly. And then the lowest
order rate would be the genetic providers
in the outpatient setting, but it’s still not zero. So our whole process is looking
at all providers, all orders to just make sure
that we can catch any errors if they are there. So I told you I was going
to talk about a couple of other processes. So this is a study
that was published by a colleague,
Jackie Riley, who is a genetic counselor
at Cleveland Clinic. And they have a couple of
different interventions that they employed, one a
clinical decision support tool. So we talked about
privileging before. So this is setup so that
for orders in the outpatient setting– this is on the graph here
in A in this pie chart– they designate certain
providers as deemed users, so experts in a specific
specialty who are allowed to order
specific types of tests. And then everybody else
gets a bump back to say, you can’t order that test. And when that fires in the
system, about half of the time the tests are
canceled, and there’s no intervention needed
from a genetic counselor or pathologist. In the inpatient setting,
they have a strict restriction that only geneticists
can order genetic testing or a consult test to happen. And so if you’re a
nongeneticist and you order it, you get a
pop-up that says, do you want to have a refer to
genetics, and they can do it? And about a quarter
of the time they do. And the rest of the time,
the test doesn’t proceed. So that was impactful and
easy, easy to implement in terms of manpower. It may be more difficult
from an IT perspective. And then Jackie also was able to
capture the impact of her case review as a genetic counselor. And so the graph here,
A, shows the percentage or the distribution
of modifications when she was involved. So over half were canceled after
conversation with the provider. And then the rest would
be modified or changed in some way, based
on her direction, with significant cost avoidance. So this next study
is from Dr. Suarez, who did his training
here at UW and is now the director of
the lab stewardship program at Stanford. And they implemented
both a proactive and a reactive approach to
their lab stewardship program. And so they review
test orders like we do when they’re
received, but they also have a formal
consultation service. So if a provider is
wondering what test to order and wants to discuss
it, they can reach out. So in this paper, they
categorize their misorders into five different groups– so clerical errors,
redundant testing, tests where they would suggest
an alternative approach, controversial orders, and
then things that they just had uncategorized. Controversial orders
are interesting, so they categorize those
as things that were not necessarily wrong, but there
was not enough clinical utility evidence for the use of that
test in that particular patient population, which is a hard
thing to argue with someone. I think for sure
in pediatrics, it’s we’re looking for
those rare conditions. And so– and you
don’t have anything to back you up to say why
it’s not a good test to do. And so when they
looked at the data, they showed that over this year
period of these interventions being in place that
the combined effort was able to curtail the
missed orders of all types. But the biggest decrease was
in those controversial orders. So even though they couldn’t
prove why it didn’t really make sense, the
fact that they can partner with their colleagues
and talk about it really did have a positive impact
on provider behavior. So genetic counselors
also have a role to play from the
payer perspective. So having genetic
counseling as a requirement was first done in 2013 by Cigna. So for a subset of
their tests, they require independent
genetic counseling by a board-certified genetic
counselor not employed by the lab. They wanted to remove any bias
that a lab genetic counselor could have to try
and encourage testing towards their lab,
which is, I think, positive but also
controversial in some ways. And then there’s other
genetic counselors that are involved in the actual
case review or lab stewardship review at the health plan. And so this information
was just published by a company, InformedDNA, who
have genetic counselors– they call them genetic analysts–
that are reviewing orders for appropriateness and helping
to facilitate authorization for appropriate tests. And of interest is just
their modification rate is very similar to what you’ll see
across other studies and then, I guess, the impact
of preventing orders that are really not needed. So shifting gears from
that real case review, I just wanted to highlight
another intervention that’s a great example of partnership
between Seattle Children’s Hospital and the
University of Washington. Preventing duplicates you
would think would be easy. You know, you don’t need to
do this test more than once in a lifetime many times. But we all are very
fluid in our health care. And so being able to capture
those duplicates across health systems can be challenging. So the problem we were
facing was duplicate orders on neonates that were delivered
here and transferred to Seattle Children’s. And so what we instituted was– it’s not simple, but there’s
a lot of communication around plans for patients
who were seen prenatally, and a testing plan was made. And then we can track when
the baby is delivered. We have a lot of communication
with the genetic counselor, with me here in the lab. And then through
that communication, over about an eight
month period we were able to prevent 11 tests. That doesn’t seem
like a lot, but we were pretty grateful
to have caught those because, basically,
the test started here. UW was going to bill for it,
and then we do a duplicate. We’re not going to get
reimbursed for that test. Also, the confusion around
where those results lie and making sure they
get into the right hands is really important to address. And so this process
has really helped to improve the care
for those kids, and we’ve gotten great
positive feedback from our neonatal intensive
care doctors as well. OK, so hopefully you won’t
fall asleep through this part. This is the part I
get excited about, but we’re going to talk about
test coding and coverage, which is an important backdrop for
some of the interventions that we have in place to try
and align our stewardship interventions with improved
reimbursement for these tests. So this is a similar diagram
that we looked at before in terms of the
new tests that are available on the market,
again information pulled by Concert Genetics. And essentially, what
they’re showing here is the products that are
available, the tests, and then, on the right-hand
side, the commercial spend. It’s probably not
surprising that the majority of the spend from payers is
in prenatal hereditary cancer and oncology treatment. But it gives us a perspective
for where we might have impact on payers and supporting
care for at least from our pediatric population
for some of that rare disease. Coding presents a fun challenge. So this diagram shows the
different combinations of CPT codes available for
hereditary breast and ovarian cancer over a
period of 18 months. The gray line shows the
unique coding combinations. So these panels
typically would at least have two genes involved. And you might use two codes. You might use many codes. And so they captured
this and all the chaos that would go along with that,
which basically then results in potentially exorbitant bills. So we’ve heard of
a $40,000 claim sent to an insurance payer
because coding was not clear. The good news is that now
there is a GSP code, which is a Genomic Sequencing
Procedure code specific to hereditary breast
and ovarian cancer panels. So in theory, you would take
away all that variability and have a single, unique code. But that still is fraught
with challenges for how people will use it or abuse it. The same would be true for
expanded carrier screening. So again, the gray line is the
unique coding combinations, and the blue line is
the cumulative effect of that, those coding fun. And these are much
bigger panels. You would expect
them to be higher. Fortunately, again, this one
has a GSP code now as well that can be used, a single code
to, in theory, capture that. And the benefit of
this for labs is that it’s a unique
identifier for your test. They can apply an insurance
coverage policy to that and make sure that we’re
using this test appropriately, and set, hopefully, more fair
reimbursement related to that, and get rid of some
of the fraud, waste, and abuse in the
system of people who might be trying to game the
system and use multiple codes. The challenge is there’s
only 33 of these codes to describe multigene panels. Each year I get excited, like
maybe there will be a new code. And there’s not ever
really a new code. So it’s not evolving
at the rate we need to, but it’s helping in some
of the biggest areas based on the spend. I did want to touch on PLA
codes, which many of you may be familiar with or not. It stands for Proprietary
Laboratory Analysis. And these are codes
that are requested by the clinical laboratory
or the manufacturer that’s offering that test. It’s a much easier
process to get a PLA code in terms of working
with the American Medical Association. And the idea of it
is that it gives you that clarity or distinct
mark for your test. I do think if– one
lens would be it puts a bull’s eye on something. It’s easier for a
payer to say, I’m not going to cover that,
which may be very fair. There often may not
be enough evidence to say why this is
clinically meaningful. But the growth in the
number of these codes is pretty astounding. I mean, it’s doubled
just in the past year. And that presents challenges
both for developing evidence for how we should utilize
this testing but also for just the claim systems. They’re not updated
that regularly to be able to have
these new codes in them. And so when we’re trying to
get preauthorization or bill with them, things are
going to be lagging behind. So while our intention is to
have a clear, specific code for a test, we may
not be able to realize that in the preauth process. So the last thing I
wanted to talk about was policy challenges. So this is a paper that’s
a little bit older. It’s from 2013. But this group reviewed publicly
available medical coverage policies for genetic tests from
65% of the largest US payers at that time and found,
not surprisingly, variation in both
the number and scope of policies related
to genetic services. Interestingly, half of
the policies identified were specifically in place
to exclude certain types of genetic testing. I find– I pulled out a
few of the common themes that I thought were of interest. So now we often tell providers,
if you want to have a test, you should really
try and articulate how that will change the
patient’s medical management. That’s the most important thing. At that time, only
half of policies even had that as an
element within them. So I’m sure that’s
probably evolving but is a logical reason for why
you might want to do a test. And then the other point to pull
out is for genetic counseling. So it was either
required or recommended, at least at that time in
many of the policies– perhaps scary that
only a few of them talk about the tests being
scientifically or clinically valid. Hopefully, it just
means it’s implied, but I think when we’re
considering quality and identifying that that
is important to include within coverage policies. OK, so hopefully you’re not
asleep or terrified because now I just want to shift
to interventions that we can do to try
and partner with payers and support our
patients in getting medically appropriate tests and
not going bankrupt doing so. So this first case is an example
from the Children’s Hospital of Pittsburgh where they
have a genetic counseling team involved in the
lab similar to ours. They were finding that when
they would receive orders, there was a lack of pre-
and post-test counseling. Informed consent
was often missing. There were new
payer requirements that said that
genetic counseling did have to come in order to
get prior authorization before the test was ordered. Obviously, they were finding
errors, duplicates as well. And the solution of
trying to just refer to the genetics clinic
was really not viable due to long wait
times and the access. And so when they looked at
the data in 2016, about 60% of the orders they had received
had no genetic counselor involvement. And so their solution was to
launch this genetic testing clinic. And the idea of the clinic
is it’s staffed daily by a genetic counselor, and
they’re just on call real time to support patients
and providers who are interested in courting–
coordinating genetic testing. So a patient will be seen,
say, by a neurologist who’s interested in a test. And they’ll talk about
the test with the family and then refer the family
over to the clinic. The genetic counselor can
collect the family history, provide pretest counseling, do
the genetic test stewardship at that point to ensure it
really is the appropriate test, obtain consent from
the family and make sure they’re really
engaged in that, and then coordinate
the logistics of testing and authorization. And then what’s great
about the clinic is the genetic
counselors are also available to discuss results
when those come back. So they basically sit in a
room doing their other work and are just available when
patients and families need them, which is a great
service, and it’s been very positively received
by the providers there. And so Jodie shared with
me some of the information from the first year. They started it in
January of 2018. And most of the
requests they received for patients seen in the
clinic were from neurology. And you’ll see they saw
350 patients, but only half of those actually had a
genetic test ordered– so interesting impact in terms
of both counseling families, ensuring they were really
engaged in that test, and then also
probably some of this is just the test
was not authorized. But by having them involved,
their insurance authorization rate was through the roof,
which is pretty great. They’ve done a nice
job of aligning with their local
payer, who is– covers the majority of the patients
they see and, by doing so, can make sure the
policies are reasonable and then be good stewards
of aligning patients to those policies. So this is something I think
would be pretty great to do at Seattle Children’s some day. So this second example is
from Seattle Children’s. And so in our population,
similarly, about half of our tests are ordered
by genetics providers, but the other half are not. And so if you are evaluated and
you have a developmental delay, and you happen to land
in genetics clinic and genetic testing
is recommended, you’ll likely see
a genetic counselor who will coordinate
preauthorization and provide pretty good patient and family
education at that point. But if you land in
another department, you may not have
that same service. And so as a result
of that, patients may end up getting bills
that are unexpected. And they don’t
complain to the doctor. They complain to the lab. So this was our current state. When we started our
program, we were not looking at orders at
the time of preauth. We were just looking when
the order was received. And so we wanted to get
upstream of the problem. And so the first thing
that we have to do– I’m actually glad that we
don’t have to do this anymore. Although it’s
journaling, so you get to draw out all your
feelings about how terrible the process is as a first start
to articulate all the waste in the system. And I just am proud
of that picture. And so what I will
pull out from that is actually the
best-case scenario. So you can tell
it’s complicated. There’s a lot of
handoffs and frustration. This is meant to be
Swiss cheese of stuff not going through or being
caught the way it should. But even in a
best-case scenario, this is what insurance
authorization looks like. So again, it was a
couple of years ago. So fortunately, genetic
tests have come down in cost. But this was the test
that we requested, had gotten authorization for. Insurance paid us
generously, $6,489. The hospital paid a portion
of that for whatever the allowed charges were. And the patient paid
their copay of $721. And so I point this out because,
great, we got authorization, but authorization doesn’t
mean that it’s fully covered. So in the process
that we set up, we really still
need to make sure patients understand
what that outcome means, and what it means
for them financially, and whether it makes sense to
go forward with testing now or perhaps wait
until they’re later in their deductible period, and
really just have transparency in the process. So that was our problem,
and our solution was to try and
create a process that was simple and transparent,
that was standardized across the institution. So regardless of who
recommended the test, they would get the same care
and that we would ensure we were having the right
person doing the right work. Previously, sometimes it
was the division chief of neurology doing his
preauth work, which was just terrible to see. We want to take that off
him so he can see patients, and we can provide that support. And so our goal, or our
approach I should say, was to get institutional
support and champions using that great drawing and to
integrate lab stewardship case review with the process. So we didn’t want to just
push through a preauth without making sure it was
really the optimal test or needed– and then make sure that we could
identify any other details that were required upfront, and
provide it, and make sure that the request would
go through efficiently. So this is what the
workflow looks like now. The provider evaluates
the patient in clinic. They may determine
that a test is needed, and then a
communication order is placed in our electronic
health record. And then they’re required to
document medical necessity for the test. And that’s it, which is great. And no sample is
collected at this point. That request then comes to our
lab genetic counseling team. There’s a rotation
of genetic counselors who review orders
that come through. And we are essentially,
again, looking to see, is it an appropriate test? If so, has the provider
selected a specific lab? Or do they want help? Sometimes it might be
a very vague request. You know, I want a
microcephaly gene panel. And at this point, we can
work with the provider to find the best panel
option for that patient. We may suggest that they
bolster their medical necessity language or add it at all. Sometimes they forget. And then our process
would be to include all the appropriate elements
to facilitate insurance authorization, so selecting the
most appropriate CPT code based on our understanding
of the coding rules and then providing whatever
necessary forms might be required for the
specific insurance plan. The information is then
transferred to our insurance processing department,
so we don’t have to talk with the payer. We get to do our best
work around really optimizing the test. And then we have a
great team of staff who communicate directly
with the insurance plan by fax and phone. And they’re just
really amazing people. But they communicate
the information and get the outcome back,
which goes to the care team. And if we get an
authorization, the care team would then communicate
to the family this test was authorized. You may have a
copay or deductible. You should call your plan to
get more details about exactly what that cost is,
and let me know if you want to proceed with testing. And if they say they do,
then the test is coordinated. So it’s a much more streamlined
process than it was before. I do think, based on our
provider satisfaction surveys, that people are pretty
pleased with the process and the support that’s provided. And we feel good because
we’re getting ahead of it from a stewardship perspective. In the previous state, we would
get an order, and they’d say, well, it already
preauthed, and the samples are already collected. Just send it. And so this gives
us an opportunity to try and optimize the
orders a little bit earlier and in partnership
with the provider. So the impact is significant. By having the integrated preauth
process with case review, 7% of those requests are
canceled with the permission of the provider. And they never
clog up the system. So it is a lot of work
for us to pass that through to the insurance
processing department then to the payer
and back again. And so we feel good about
removing waste from the system and doing our part. And then a good chunk of the
time, maybe 4% of the time, we’re improving the
request in some way. And again, the
majority of that is related to improve
necessity documentation. We’ve done a lot of work to
integrate payer requirements. So it feels a little
bit like every month there’s some new
form or new process that we have to jump through. But because of the
way we’ve set this up, we’re able to protect
our clinicians from that. They can do their best work. And then we are able
to integrate that into our workflow and
prevent a lot of the back and forth with the payer
for these requests. So an example would be Aetna
now requires a specific form to be completed, the
documents, pretest counseling for an exome, and we can make
sure that’s completed upfront before we send the request
through to the payer directly. And it goes much more smoothly. It seems silly, but it really
is a big win for those patients and prevents delays for them. We also look at requests
that are denied. So we did some work with our
genetic counseling assistant to help support providers
when a request was denied, figure out the best way
to appeal the request. And so by doing that,
we could categorize the reason for the denials. And of the 70 requests that
we looked at or captured, 11 of them we were able
to overturn and get an authorization for that test. And the reason for those
denials was pretty enlightening. So it was simple things
like the wrong policy was applied to the
request that we submitted, or a piece of information that
we thought we had been faxed honestly hadn’t been faxed. It seems really silly. But details that may not
have been figured out by the ordering provider
or taking the time to do, that we could
capture and ensure we get the authorization in place. Of interest, there
were many of those that were denied for being
experimental-investigational. And those are really
hard to overturn, and that was our experience. So we tried our best
to write letters that we thought were compelling. But in the end,
none of those were overturned, which is probably
not a surprise to some. But it was helpful for
us to say, we tried. Here’s the many,
many that we wrote. And then we went back to our
insurance processing department and showed them the data. And they modified the
workflow a little bit. So for patients with that
specific type of insurance, they would just stop and say,
based on the denial reason, it’s not worth going through
the appeal at this point. We can proceed. Your options are apply
for financial assistance or proceed, and this is what
your out-of-pocket would be. And they would have
that information much earlier in the
process rather than us doing this futile loop of
trying to overturn the denial. So that was really
beneficial but frustrating when there aren’t policies
that cover tests we think are appropriate. So the other thing
that we’re working on is really advocating for
appropriate coverage policies. And that’s done
both nationally– and I’ll talk about that next– but also at a local level. So Washington is unique from
our Medicaid perspective that we have a health
technology committee that reviews different
types of genetic tests or other services. And there’s an
opportunity for us to weigh in on the coverage
for those types of tests. So a few years ago, they
finally started covering chromosomal microarray. And we were able
to provide feedback and I think have landed
on a policy that is very reasonable for those patients. And just a plug,
they’re going to be looking at exome
sequencing on November 22. It’s a very interesting
process if you’re– have any interest in going to
hear that or provide feedback. It actually seems
very reasonable. Through the process of getting
the microarray policy in place, we were able to
build a relationship with the medical director
at Washington Medicaid. And she is a lovely
person who’s really engaged in trying to make sure
that the coverage policies are appropriate for our patients. And that was a secondary
benefit I don’t think we knew would come along. OK, so in the last few minutes,
I do want to mention PLUGS. Mike did the honor of
actually saying all the words, but I’ll do it again. PLUGS stands for a
Patient-centered Laboratory Utilization Guidance Services. And our mission
is to improve test ordering retrieval,
interpretation, and reimbursement. And we– currently, it’s a
membership-based organization run out of the Department
of Laboratories at Seattle Children’s. And we have children’s
hospitals, adult institutions, reference labs,
and other companies that are all focused
around this mission to improve test ordering,
retrieval, interpretation, and reimbursement. And the work of PLUGS
is sort of fourfold. So we really
started in this area of providing tools for
stewardship program development. So what we try and do with PLUGS
is share our best practices with members, and
then it’s a great way to learn from members. So for example, Jodie Vento in
the work at Children’s Hospital of Pittsburgh is
very inspiring to us to want to see if there’s
ways we can adopt that into our own practice. And she’s great at
helping us to do that. The second initiative
relates to case management. So for institutions
who are not going to hire their own
genetic counselor or maybe just don’t have the
volume of requests that really need a full-time person, this
is a remote genetic counseling service that can be
involved to review test orders for appropriateness. Laboratory stewardship
standards are important. The idea is to create
a set of standards that demonstrate good laboratory
stewardship principles. And if we can show that
we’re doing this great work and demonstrate that both
to patients and to payers that that should help us to
become a network laboratory– laboratories and improve
reimbursement rates that way. And then the last initiative
is our insurance alignment, and that’s what I’ll
talk about at the end. So again, if we’re going
to do all this work to ensure the test
is appropriate and show the we’re
good stewards, it would really be
nice to make sure that the testing is reimbursed. So we do that in a
couple– well, many ways, but I’m going to highlight two. So the first is medical
policy development. So we knew exome sequencing was
exciting, and a lot of people were not covering it. And so we created
a coverage policy that we think is reasonable
for exome sequencing and made it freely available
on the PLUGS website. So payers can go. We want them to steal the
policy and implement it. You can make edits
to the policy. But the idea is that
it’s created by experts, is going to provide
reasonable coverage, and we hope will be
implemented broadly. And for exomes, it was. So I know you often are surfing
the Aetna website looking at their coverage policy. But if you did and you pulled up
our PLUGS policy and the Aetna policy, it’s word for word,
their coverage criteria, which is awesome. So we feel pretty
excited about that, and we want that to
continue happening. And so our most recent policy,
just hot off the presses, is for rapid genome sequencing. And so this will– it’s intended for
genome sequencing, and in our critically
ill neonate population, and is more on the
leading edge, I think. There’s not a lot of
coverage policies that exist. So we’re really excited
about the impact that this can have for patients. And so our goal
again with PLUGS is to make this freely
accessible to disseminate through our relationships,
both with labs and with payers, so that people will adopt it. And then, ultimately,
patients are getting that better service. The other work I’m excited
about relates to that grievance procedure, trying to get
denials overturned for tests that we think are
medically appropriate, so not stuff that we think
was a long shot or really wasn’t, but things where either
the coverage policy is outdated or perhaps the criteria just
wasn’t applied correctly. And that’s actually pretty
difficult to navigate. And so we have tools that
are created for patients and families that
help them understand just the language around
insurance authorization and then how to
navigate that process. So it’s checklists
and guidance on how to get what was the
not– why was it denied? And what are my rights
for appealing that? And so that’s brand new. And we’re excited to see the
impact that it can have and use it for our own patients as
well at Seattle Children’s. And then also just
guidance for providers, most of the providers
grumble because, again, we’ve made it really easy for them. They just have to
put in this one order and hopefully write a note
about why they want a test. And so if they get a denial,
navigating that appeal process can be frustrating. And so we’re trying to
create tools for them to be successful in
that as well, which ultimately helps patients. OK, so in the end,
final stretch here, future challenges
or opportunities– genetic counselors
are eternal optimists. I just wanted to give you sort
of my predictions for what’s coming, probably
nothing surprising, but certainly I
think the increase in patient-directed testing
will challenge the framework for genetic test stewardship. I’m eager to rise
to that challenge. But we conduct a provider
satisfaction survey each year as part of our stewardship
program at Seattle Children’s and this year asked a
question specifically related to patient-directed testing. And 40% of the
providers surveyed said that they had encountered
patient-directed tests and had a desire for support
in saying no to these. And this is one of the quotes,
“23andMe comes up often. I feel like this correlates
with increased advertising. MTHFR is the repeat
offender with these tests– and thankful I have a hard stop
with not offering that test here.” We did obsolete that test. And on the test
catalog, it pops up and says there’s no
utility for this. We won’t even collect it. You can’t have it. And so the doctor can just
point to that and say, sorry, I can’t offer that to
you here, which is really great. Thank you, Darcy,
for that great work. But 23andMe is
difficult. So I think we have an opportunity
to support our providers and then, ultimately,
patients in understanding, what are the tests that
they’re really seeking? And how do they assess
the quality of those? So the evolving genetic
testing landscape is job security for
genetic counselors, which I’m excited about. But the accessibility
of genetic testing will again continue to
challenge our framework. I think for– if a family has
done 23andMe or something– I don’t mean to keep
picking on that. But some of that
direct-to-consumer testing, it’s cheap. It’s fast. It’s easy. And then I want to talk to them
about a clinical test that’s meaningful and will impact their
care but is more complicated and might cost them $500. How do I have that
conversation and have them understand the
value of that test and how it might
impact their care? So I think that does sort of
challenge or blurs the lines. You can check out
this great article written in Clin Lab
News about blurred lines and direct-to-consumer testing. Innovation– so novel
technologies are exciting. Figuring out how to
assess those technologies and determine when they’re
ready for prime time will keep us all
thinking day to day. I’m grateful for the work
at Seattle Children’s where we can consider tests that we
believe will be beneficial, but we’re not really ready to
start charging the insurance payer for it until
we’ve set up a mechanism for being prescriptive
about how we’re going to use that technology,
and then gathering evidence for its impact, and then really
only starting to utilize it and bill insurance
for it when we feel like it’s really appropriate. And then through PLUGS, we
can create a medical coverage policy that we think makes
sense and disseminate that. And I think some of
those creative ways of dealing with
novel technologies are really going to be needed. And then the last, quality– how do you really
assess quality? It is really hard
to figure out what we’re paying for with
the tests that are being offered in the market. At 14 new tests today, I
don’t know how we can possibly keep on top of it. And then the question
of, is a bad test better than no test at all? I’m sure many of you
have heard about sort of pharma-supported, no-charge
testing at various labs, some of which are great, some
of which may be not as great. And the question is, and
just because it’s free is that really better
than no test at all? And I’d argue maybe no. And so I think, again,
these are things that we’ll all need to consider
and will keep us engaged for the next many years. So I end with, how can you
be part of the solution? So hopefully, I’ve
given you a framework for understanding the goals
of laboratory test stewardship and recognizing your role in
the genetic testing process. I know many of you are
developing assays, or running assays, or involved
with counseling patients around them, or you’re
patients yourself, and so– or your
families are patients. And so figuring out how
to have shared language around test stewardship is
important for the success of all of this. Hopefully, I’ve described the
role of genetic counselors, and how we can partner through
the genetic testing process, and that payers aren’t
always the bad guys, that there’s an
opportunity to align, and that, oh, my
wish if we could– if it happens is for no more–
and it’s genetic counselors too, to say, well, I don’t know
that you really need the test. But we’ll just see if
insurance will pay for it. And if they don’t, then
we just won’t to do it. Don’t do it. Don’t do the test. It’s really not needed. And ultimately, you
are going to pay. So that is my wish for you. And I just want to
end by acknowledging all my colleagues, all who
filled the audience with love, which is great, but
truly specifically Dr. Astion and Dr.
Dickerson, Monica for helping to make my role in the lab be– come to fruition, and all my
colleagues in the audience, the clinical genetic counselors
at Seattle Children’s, our stellar team in Sendouts
and Client Services, the Insurance
Processing Department. Emily Prince is a gem who
does all this preauth work– and our operations team
at Seattle Children’s, thank you, everyone. And with that, I’m happy
to take any questions. I’m going to leave you with
a couple of resources– shameless plug for PLUGS,
but there’s great information there, including the policies. Share them with your
payers if you happen to be talking with someone. And this book has some
information around laboratory genetic counseling too. So thank you very much. [APPLAUSE] Yes. AUDIENCE: Jessie, thank
you, seeing that we hang, what, a couple times
a year [INAUDIBLE] I understand this
process for rare tests for which testing
is super expensive. Do you follow the
same process though for some more common things,
like global disorders, or cystic fibrosis, or
something like that? JESSIE CONTA: We actually do. That’s a great question. I’m going to repeat it. So the question
was, I understand the process for expensive,
rare genetic tests. But what about more common tests
that may be less expensive? I think I’ve captured
that right, Dan. So our process is
really to capture all. And part of that is because
there are insurance coverage policies that require
preauth for those tests even though they
don’t cost very much. And we want to be
able to capture those. And cost is relative too. So $300 may not seem like a lot. But if it’s the
family paying for it, we want to make sure
that that is transparent. Yes. AUDIENCE: So under direct
consumer testing [INAUDIBLE] noticed that Ancestry
DNA said that they’d get into the health business. And it’s more lab. And their model– well,
[INAUDIBLE] genetics model is one of you pay for the test. Then you get a subscription for
the genetics health service. I’m wondering if
you think that that has any role at
all in health care to have something to
subscribe to a service to have genetic health
updates regularly? JESSIE CONTA: How do
I even answer that? So the question, to
restate– and let me make sure I’ve
got it right, Brian– is for services
like Ancestry, who are direct-to-consumer testing
services that are now expanding into providing a more health
service where you would get periodic updates on your
health and are really subscribing to that seemingly
full, wraparound care. So I think there are some
services that are great. And I don’t know about
Ancestry’s service, honestly. There are services where
you can enter your genetic information– say you’ve
already had genetic testing– and track your
variant over time, and be able to learn
new information about the interpretation
of that variant. That I think is very helpful. I think– you know, I’m not as
familiar with the other ones. But I do think it’s going to
challenge our way of providing health care because
people are going to be coming in with reports
from these other places. And this consultation
service is going to be telling me I
need to go to my doctor and tell them to
do this one thing. And then that puts doctors
and then ultimately us– down the line, if
they’re doing testing– in a hard place. So I think
partnership is the way to go to understand what
they’re doing and be aware of it so that we know how to
react appropriately. AUDIENCE: Has anyone looked
at the costs of the services that you’re providing verse– you talked about a
million dollars, say, approximately of benefits
of cost avoidance. But the fact is our
administrative costs should increasingly
coming up, increase. So the net increase to
the health care system is going to be the
administrative overhead in this kind of service. Do you– have you
looked at that side? JESSIE CONTA: That is a great
question and a very good thing to point out. Because we do– it’s
difficult to capture the actual cost of doing
the service versus the cost avoided, and anything
reimbursed, and all that. So we definitely oversimplify it
but by stating the avoided cost for the test. For us, our strategy
and the strategy we try and say for others is
to have a diverse portfolio, I guess. So our genetic counselor team,
we can justify much of our FTE by this work, but we also
support our internal genetics lab and have other
consulting work that we do that helps
to offset salaries. When we look at other
organizations within PLUGS and help them try and
justify the service, typically, for expensive
tests, the cost avoidance is enough to justify
it and then some. The part that I think
is less tangible is the work of all
the people around it. So I mentioned
and acknowledged– I should put them back up
because they are so great– is all of the people in the
lab in the Insurance Services Department who do this work. And that is difficult
to quantify. But I do think
that they’re going to be doing work for stuff
they didn’t need to do. So getting rid of
the work they didn’t have to send out
hopefully is offsetting some of those other processes. But maybe doing a deep dive
into the cost, the true cost, is a good next step. AUDIENCE: All
right then, I would like to thank Jesse Conta
for a great presentation and thank everybody
for coming today. [APPLAUSE] [MUSIC PLAYING]

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